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Medical Devices – sterility validation

In the Instruction for Users, supplied with reusable medical devices or medical devices to be sterilized by the user, there should be a validated instruction for sterilization. We can validate the sterilization of your product, according to e.g. EN ISO 17665:2006 (for autoclavation)

Cause

Contribute to healthcare safety by having clear and validated instructions for sterilization.

Fulfill requirements in MDR.

Method

Sterilization validation is performed by showing complete killing of minimum 106 colony forming units of, for the method, most resistant organism.

Deliveries

Methods and results are presented in a written report.

Ordering

Please find contact information below

Facts

Service

Medical Devices – validation of methods for sterilizing products

Innovation area

Chemical and biological analysis, Medical devices

Price

Please contact us for price information

Preparations

The customer prepares the test items unless otherwise agreed

Josefin Caous

Contact person

Josefin Caous

Forskare

+46 10 516 59 96
josefin.caous@ri.se

Read more about Josefin

Contact person

Karin Agrenius

Ingenjör

+46 10 516 59 42
karin.agrenius@ri.se

Read more about Karin